NCT07006974

Brief Summary

The goal of this cohort study is to investigate the clinical characteristics of SMCs and to explore the difference in cardiovascular outcomes in comparison to age-, sex-, and admission year-matched HCM patients. The main question it aims to answer is:

  • Do patients with SMCs have higher rates of cardiac outcomes?
  • What risk factors do SMCs patients experience a poor prognosis?

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

May 28, 2025

Last Update Submit

January 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • primary outcome

    a composite of all-cause death, hospitalization for heart failure, myocardial infarction, ischemia or hemorrhagic stroke (excluding transient ischemic attack), other thrombotic events, and modified International Society on Thrombosis and Haemostasis crit

    3 years

Interventions

SMCsOTHER

patients with SMCs

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The investigators identified patients with SMCs by screening the electronic database. Gene testing and muscle biopsy were used to confirm the diagnosis of SMCs. (Part two) Patients with HCMs were included as the controls of SMCs who had LVH and available CMR data in our study. The diagnose of HCM was according to the 2024 ESC Guidelines of HCM but without evidence of SMCs. Controls were matched 1:2 to each case based on sex, age (matched within ± 5 years), and admission year (matched within ± 12 months).

You may qualify if:

  • patients who were diagnosed SMCs or HCM. Gene testing and muscle biopsy were used to confirm the diagnosis of SMCs. The diagnose of HCM was according to the 2024 ESC Guidelines of HCM but without evidence of SMCs.
  • complete baseline data
  • accessible follow-up data

You may not qualify if:

  • incomplete baseine data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Liang

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 5, 2025

Study Start

May 27, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 8, 2026

Record last verified: 2026-01

Locations